Training And Innovation Networks For Sustained Capacity Development Related To Ethics, Regulatory, Pharmacovigilance, And Related Digital Regulatory Platforms

Expected Impact

Through strategic capacity building, digital transformation, and cooperation in SSA, the actions funded under this topic should contribute to the establishment of a resilient and future-ready ethics, regulatory and PV environment.

Applicant consortium

If requested by the applicant consortia, the EDCTP Association may offer technical support for the preparation of their proposal, in particular because of the lump sum nature of the Grant Agreement. The applicant consortia may also decide to include the EDCTP Association as coordinator. In that case, the applicant consortia should contact the EDCTP Association to obtain the estimated amount of the Association’s contribution as well as any other relevant information. The EDCTP Association will timely provide the necessary information to all potential applicants.

Background

Ethics bodies, regulatory agencies, and pharmacovigilance (PV) systems in sub-Saharan Africa (SSA) continue to face significant challenges that hinder effective provision of healthcare services, safety reporting and timely regulatory approval for clinical trials, and marketing authorisation of products. These challenges are largely attributed to limited resources, limited training provision and access to mentor expertise, governance constraints, disparities in digital infrastructure, and limited regional and international regulatory alignment. In response, initiatives such as the African Vaccines Regulatory Forum (AVAREF), the African Medicines Regulatory Harmonization (AMRH) Programme and most recently the African Medicines Agency (AMA) have been launched to address these gaps. International bodies, including the World Health Organization (WHO), along with partnerships in SSA, have contributed to bridge the gap by offering technical support, training, and resources to strengthen ethics, regulatory and PV capacities. Public-private partnerships have further supported ethics and regulatory capacity strengthening, safety monitoring systems, including the development and integration of digital health technologies to enhance adverse event monitoring and reporting, and to accelerate the regulatory submission and assessment processes through collaborative or joint reviews.

As per the WHO publication of October 2025^[1], eight SSA National Regulatory Authorities (NRAs)—Ghana, Nigeria, South Africa, Tanzania, Rwanda, Senegal, and Zimbabwe—are classified by WHO as Maturity Level 3 (ML3), indicating reasonably established and functioning regulatory systems. Nevertheless, major hurdles remain, such as the lack of harmonised regulatory standards and timelines, underfunded research ethics committees (RECs) and NRAs, disparities in institutional and digital capacity and sustainability of the systems set up. These issues hinder the timely and consistent evaluation of research protocols and/or applications for marketing authorisation for diagnostics, medicines, and vaccines across the region.

Despite the increasing participation of SSA countries in the WHO Programme for International Drug Monitoring (WHO PIDM), PV systems in many SSA countries remain underdeveloped and insufficiently integrated into national healthcare systems. This is reflected on both pre- and post-authorisation safety monitoring, where systems are weakened by poor digital infrastructure, limited laboratory capacity for confirmation of suspected events, weak reporting tools for data capture and interpretation, and a shortage of trained personnel. This limits the region’s ability to ensure effective PV and safety of medicinal products.

Building on the progress made through previous EDCTP initiatives^[2], this call aims to scale and sustain these efforts by establishing training, twinning, and innovation networks, leveraging existing networks where applicable that will bolster workforce capacity in ethics, regulatory, and PV and harmonisation of processes and timelines. Central to this approach is the development of a robust digital health ecosystem, which will allow seamless collaboration and enhance the operational efficiency and responsiveness of ethics, regulatory, and PV frameworks through the integration of data-driven technologies and digital infrastructure, including artificial intelligence (AI) when considered appropriate, catalysing the approval and implementation of health solutions in SSA.

Expected Outcomes

Proposals submitted under this topic should aim to deliver results that are contributing to increased regulatory capacity of (national, regional (supranational) or continental) Regulatory Authorities for the clinical trial oversight, registration and marketing authorisation and/or PV functions to operate at WHO maturity level 3 (ML3) as benchmarked against WHO Global Benchmarking Tool^[3] for medical products (therapeutics and vaccines) and/or increased research ethics oversight capacity using the WHO Research Ethics Oversight Benchmarking tool^[4] including streamlining and coordinating ethics oversight for multi-centre trials for medical products (therapeutics and vaccines) within countries.

In addition, proposals are expected to lead to at least two of the following:

1. Improved digital infrastructure including emerging digital technologies (i.e. AI and/or big data) in SSA for the assessment of clinical trial protocols by RECs and/or regulatory authorities and/or applications for marketing authorisation by regulatory authorities.
2. Availability and accelerated use of digital technologies and data analytics, for real-time safety data monitoring and reporting, and timely PV data sharing across countries in SSA and globally through PIDM, for pre- and post-authorisation PV processes.
3. Greater harmonisation, coordination and streamlining of research ethics processes within countries to allow for efficient processes for ethics review of multi-centre trials.
4. Greater alignment and cooperation across countries in SSA regarding global standards in ethics, regulatory and PV.
5. Greater preparedness for emergency use authorisation [incl. authorisation of Monitored Emergency Use of Unregistered and Investigational Interventions (MEURI)] through implementation of accelerated and harmonised processes.

Scope

Proposals submitted under this topic should address persistent gaps in ethics, regulatory and/or PV systems evaluating medical products (therapeutics and vaccines) by strengthening existing and/or building new networks:

1. Proposals should address the capability to provide scientific advice, enhancement of knowledge on assessing complex innovative clinical trial applications (included but not limited to platform trials) and/or assessing marketing authorisation files, and/or PV capabilities including AI and big data as appropriate, strengthening capacity for ethics committees and/or regulatory agencies that did not reach ML3 for the corresponding areas as defined in the WHO Global Benchmarking Tool, while benefitting from mentoring/peer support by ML3/ML4 agencies as part of the consortium.
2. Proposals should establish and strengthen training and twinning networks or a regional regulatory authority dedicated to training ethicists and regulators to ensure sustainable capacity for Ethics Committees, and/or Regulatory Authorities and/or PV across countries in SSA in alignment with international standards.

In addition, proposals should address minimum one of the below:

1. Building national and/or regional/continental ethics and regulatory capacity to utilise digital technologies, improving the review and approval processes and knowledge of clinical trial applications (including acceleration through parallel ethics and regulatory review), and/or marketing authorisation of medicinal products.
2. Improving integration of PV systems into national health systems by building and utilising digital reporting mechanisms and data sharing across countries in SSA in alignment with international standards:
   1. Implementation of collaborative digital platforms for accelerated use of digital reporting mechanisms to support joint reviews and collaboration in PV, enabling more efficient sharing of data on Adverse Drug Reactions (ADRs) from site to national systems and beyond national (e.g., WHO Programme for International Drug Monitoring (PIDM)) and/or
   2. Improve safety reporting by improving the quality of the adverse event reports as well as enhancing the geographical coverage of the reported data, and/or
   3. Strengthen pre- and post-authorisation PV systems including risk-benefit analysis.
3. Improving regulatory and ethics framework and infrastructure for emergency preparedness:

• Harmonisation of processes, fostering reliance, implementation and use of digital collaboration platforms to support joint reviews.
  1. Establishing continental and global ethics and regulatory peer support and twinning networks.
  2. Establishing continental and global regulatory innovation networks working on alternative pathways for licensure and on the vision of “ONE WORLD, ONE DOSSIER”.

Proposals should ensure capacity building across countries in SSA, including a leadership development program such as training of trainers for ethics capability building, and knowledge sharing across countries in SSA.

Proposals should address how to increase awareness and development of policy on data protection in the context of storage of data when relevant.

Proposals are encouraged to consider capacity strengthening strategies that align with the One Health Approach^[5].

Proposals are encouraged to address relevant ethics, legislative and regulatory gaps most pertinent to the SSA countries for strengthening the (digital) platform and to extend the region covered addressing regional/continental needs.

Proposals are encouraged to ensure that ethics and regulatory capacity strengthening are well aligned and progress in parallel.

Applicants should provide methodologies for translating research findings into public health practice and policy guidelines and are encouraged to follow guidance provided in the EDCTP Knowledge Hub Research into Policy Toolkit.

Proposals should engage communities and relevant stakeholders, most notably (local) key opinion leaders, researchers or clinical Investigators, health care professionals, policy makers, public health authorities and end-users.

Out of scope: Capacity building related to Manufacturing activities for pharmaceutical/vaccines products including but not limited to batch release, support for local manufacturing of active pharmaceutical ingredients (APIs) and Technology Transfer, diagnostic production, financing, strategic and policy Support Mechanisms for manufacturing are out of the scope of this topic. However, the scope includes strengthening of NRAs capacity to carry out manufacturers inspections enabling registration and marketing authorization of medical products.

Financial contributions from third parties (e.g., foundations) interested in this scheme are encouraged to contribute to increase the budget, diversity and impact. The purpose of this topic is to fund different regions and varied portfolio of ethics, regulatory and PV projects. The granting authority will therefore base its funding decision relevant to this topic on the ranking of the proposals considering diversity of the geography and topics (Ethics/Regulatory/PV) in the proposals that are graded above the threshold.

Activities such as willingness to enter into technology transfer agreements with their counterparts - including the provision of patents, technical knowledge and know-how, or early engagement with regulators or with African manufacturers to support the translation into affordable products adapted to the regional market to be done in collaboration and coordination, when possible, with the AU-EU Health Partnership’s Manufacturing and Access to Vaccines, medicines and health technologies (MAV+) hub or similar African initiatives are encouraged to be done outside the scope of this topic.

Applicants are reminded of the expectation that proposals should come from research consortia with a strong representation of institutions and researchers from SSA countries, including active participation of Franco/Lusophone institutions. Collaboration with other international research groups with relevant experience is very much encouraged.

Proposals should include the development or implementation of common indicators (e.g., WHO benchmarking data tools) in assessing the status and functioning of Ethics Committees or Regulatory Authorities towards alignment with global standards.

[1] List of National Regulatory Authorities (NRAs) operating at maturity level 3 (ML3) and maturity level 4 (ML4)

[2] EDCTP1-Project-Portfolio-2003-2015.pdf; EDCTP2-Project-Portfolio

[3] WHO | Global Benchmarking Tools

[4] WHO | Benchmarking tool for ethics oversight of health-related research in humans

[5]